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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019733
Receipt No. R000022788
Scientific Title Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Date of disclosure of the study information 2015/11/10
Last modified on 2015/12/28

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Basic information
Public title Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Acronym Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Scientific Title Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Scientific Title:Acronym Effects of repetitive transcranial magnetic stimulation on cortical plasticity
Region
Japan

Condition
Condition healthy subjects, movement disorders
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of repetitive transcranial magnetic stimulation on cortical plasticity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes Primary outcome measure is cortical plasticity assessed by neurophysiological and behavioural measures up to 3 hours after the intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Real repetitive transcranial magnetic stimulation within 30 min for single session, repeated up to 10 sessions.
Interventions/Control_2 Control repetitive transcranial magnetic stimulation within 30 min for single session, repeated up to 10 sessions.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria healthy control and patients with movement disorders
Key exclusion criteria The only absolute contraindication to TMS/rTMS is the presence of metallic hardware in close contact to the discharging coil (such as cochlear implants, or an Internal Pulse Generator or medication pumps). In such instances there is a risk of inducing
malfunctioning of such implanted devices.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Hamada
Organization the University of Tokyo Hospital
Division name Neurology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5800-8672
Email mhamada-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Hamada
Organization the University of Tokyo Hospital
Division name Neurology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5800-8672
Homepage URL
Email mhamada-tky@umin.net

Sponsor
Institute Departemtn of Neurology, the University of Tokyo Hospital
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 10 Day
Last modified on
2015 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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